1. Field of the Invention
This invention relates to a method for collecting human cells from a body cavity for subsequent testing and more particularly to a method for collecting such cells which may be self-administered.
2. Description of Prior Art
Since conception by Papanicolaou many years ago, the acceptance and utilization of cytodiagnosis has continued to expand. Today, a number of techniques involving multiple organ systems are available, all derived from the basic concept that comprehensive pathophysiologic changes may be recognized and evaluated a expressed at the cellular level.
Exfoliative cytology ("Pap test") has long been established as a highly accurate diagnostic tool allowing identification of a number of inflammatory, premalignant and malignant states or conditions. It has proven to be a critical technique in the early detection and treatment of lesions of the cervix and vaginal vault.
The simplicity of the procedure and its accuracy have resulted in its routine use by health care personnel and its wide acceptance by the patient population. Currently, the cell sampling is performed by a physician, nurse, or cytotechnologist using an applicator to obtain the appropriate cell sample. Smears are made immediately on slides which are then fixed to insure cell preservation and to eliminate artefactual changes which could result in misdiagnosis. There are several significant drawbacks with this technique:
1. It requires a trained health professional to take the smear. The time and cost involved thus deprive a significant portion of the population the opportunity of being tested for various pathophysiologic changes and conditions, including cancer.
2. The ability to make a satisfactory slide smear from the sample varies widely as does the expertise of those performing the test.
3. The inclusion of a pelvic examination in a physical examination is becoming less universal as medicine continues in its pattern of specialization. There is a definite trend, particularly in the United States, toward sending patients to a gynecologist for a pelvic exam and eliminating such an exam from the routine office physical.
It would be advantageous, therefore, if a modified cell sampling technique were available which would allow self administration, i.e., self sampling, combined with technical uniformity. The time and cost limitations in the use of the Pap test would thus be eliminated.
Accordingly, it is the principal object of the present invention to provide a simple, inexpensive and accurate method for self-administered cell sampling in a body cavity.
It is a further object of the present invention to provide a method for a self-administed cell sampling in a body cavity requiring minimal patient instruction.